An observational study in HEPATITIS B CHRONIC, Hepatitis D and Periodontitis, sponsored by Research Center of Periodontal-Systemic Interactions. Recruiting at 2 sites in Romania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Research Center of Periodontal-Systemic Interactions · Observational
Periodontal disease is a chronic inflammatory condition associated with systemic diseases, highlighting the concept of periodontal medicine. This study aims to investigate the relationship between periodontal inflammation, oral lesions, and hepatitis B+D infection, with or without bulevirtide treatment. Oral-periodontal clinical parameters and targeted inflammatory biomarkers in saliva and gingival crevicular fluid will be evaluated in three groups: patients with hepatitis B+D receiving bulevirtide, patients with hepatitis B+D not receiving bulevirtide, and healthy controls.
Periodontal disease is characterized by chronic inflammation and destruction of tooth-supporting tissues. Emerging evidence links oral inflammatory conditions with systemic diseases, forming the basis of periodontal medicine. Hepatitis B+D infection is associated with systemic inflammation and immune dysregulation, yet little is known about its impact on oral health and inflammatory mediators in oral fluids.
This prospective, observational case-control study will recruit adult participants from the University of Medicine and Pharmacy of Craiova. Participants will be divided into three groups:
Hepatitis B+D - Bulevirtide: Patients receiving bulevirtide therapy.
Hepatitis B+D - No Bulevirtide: Patients not receiving bulevirtide.
Healthy Controls: Systemically healthy adults.
Clinical oral-periodontal examinations will be performed by a specialist periodontist, with photographs documenting oral findings. Saliva and gingival crevicular fluid will be collected using non-invasive methods to measure targeted inflammatory biomarkers. Biological samples will be analyzed at the Immunology Laboratory of the University of Medicine and Pharmacy of Craiova and at the University of Amsterdam.
Assessments will be performed at baseline and 6 months. Relevant clinical data will be extracted from medical records following data protection regulations. Statistical analysis will evaluate associations between periodontal inflammation, oral biomarkers, and hepatitis B+D status, as well as the potential impact of bulevirtide therapy.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 25 is below the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →This is the only study on the registry with Research Center of Periodontal-Systemic Interactions as lead sponsor.
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The study population includes adult patients diagnosed with hepatitis B and D co-infection who are treated and followed at the Gastroenterology Clinic of the Clinical Emergency County Hospital Craiova. These patients will be divided into two cohorts based on treatment status: those receiving bulevirtide therapy as part of routine clinical care and those not receiving bulevirtide treatment.
A third cohort will consist of systemically healthy adult individuals without hepatitis B or D infection, recruited from the Periodontology Clinic of the University of Medicine and Pharmacy of Craiova, who will serve as a control group.
All participants will undergo oral-periodontal clinical examination, oral cavity documentation, and non-invasive collection of saliva and gingival crevicular fluid for the evaluation of inflammatory biomarkers. Assessments will be performed at baseline and after 6 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients diagnosed with hepatitis B and D co-infection who are receiving bulevirtide therapy as part of their routine clinical management. Participants will undergo oral-periodontal clinical examination, oral cavity photography, and collection of saliva and gingival crevicular fluid for analysis of inflammatory biomarkers at baseline and after 6 months.
Drug: Bulevirtide
Adult patients diagnosed with hepatitis B and D co-infection who are not receiving bulevirtide therapy. Participants will undergo oral-periodontal clinical examination, oral cavity photography, and collection of saliva and gingival crevicular fluid for analysis of inflammatory biomarkers at baseline and after 6 months.
Other: No intervention
Systemically healthy adult individuals without hepatitis B or D infection, recruited from the Periodontology Clinic. Participants will undergo oral-periodontal clinical examination and collection of saliva and gingival crevicular fluid for comparison of periodontal clinical parameters and inflammatory biomarkers with the hepatitis B+D groups.
Other: No intervention
Bulevirtide is an entry inhibitor used for the treatment of hepatitis B and D virus co-infection. In this observational study, patients receiving bulevirtide therapy as part of their routine clinical care will be evaluated for oral-periodontal clinical parameters and inflammatory biomarkers in saliva and gingival crevicular fluid.
Patients diagnosed with hepatitis B+D who are not receiving bulevirtide therapy and are evaluated for comparison of oral-periodontal parameters and biomarkers.
Systemically healthy individuals without hepatitis B or D infection serving as the control group for comparison of oral-periodontal parameters and inflammatory biomarkers.
Salivary inflammatory biomarker levels
Quantitative assessment (pg/mL) of selected inflammatory biomarkers (e.g., IL-1β, IL-6, TNF-α) in saliva samples collected from participants in all study groups to evaluate the association between periodontal inflammation, hepatitis B+D infection, and bulevirtide treatment.
Time frame: Baseline and 6 months after initiation of treatment
Gingival crevicular fluid inflammatory biomarker levels
Measurement (pg/mL) of targeted inflammatory mediators (e.g., IL-1β, IL-6, TNF-α) in gingival crevicular fluid samples to assess local periodontal inflammation and its relationship with hepatitis B+D infection and bulevirtide therapy.
Time frame: Baseline and 6 months
Probing Depth (PD)
Measurement of periodontal probing depth (in millimeters) at six sites per tooth to assess periodontal status in all study groups.
Time frame: Baseline and 6 months
Clinical Attachment Level (CAL)
Assessment of clinical attachment level (in millimeters) to evaluate periodontal tissue destruction.
Time frame: Baseline and 6 months
Bleeding on Probing (BOP)
Percentage of sites exhibiting bleeding on probing as an indicator of gingival inflammation.
Time frame: Baseline and 6 months
Plaque Index (PI)
Assessment of dental plaque accumulation using a standardized plaque index score.
Time frame: Baseline and 6 months
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